Kornimate/medical-research-clean huggingface dataset:
acceptance and commitment therapy for family caregivers of people with dementia

Conditions: Psychological Distress

Summary: the pilot project aims to investigate the feasibility and the preliminary efficacy of a guided online acceptance and commitment therapy (act) intervention for distressed family caregivers of people with dementia. a one-group pretest-posttest design (n=15) will be used to investigate the potential effects of the 10 weekly online act intervention session on caregivers' outcomes at posttest (10 weeks).

this project will employ one-group pretest-posttest design to investigate the potential impact of a guided online act intervention on improving quality of life and psychological health in distressed family caregivers of people with dementia. after the baseline evaluation, eligible caregivers will receive 10 weekly act sessions, individually delivered by a licensed professional counselor online. each session lasts for one hour. primary outcome measures will be psychological distress measured by the depression, anxiety and stress scale (dass)- 21 and care-related quality of life measured by the care-related quality of life instrument (carerqol). a one-time interview at the completion of the 10 weekly sessions will be conducted to explore caregivers' experiences in the intervention.

Eligibility criteria:
inclusion criteria: 1. community-dwelling adults (age 18 or over) who are currently taking primary responsibility for the care of a relative with dementia living in the community 2. devoting at least 1 hour daily to the care of the relative with dementia 3. having cared for a relative with dementia for at least 3 months 4. suffering at least mild symptoms of psychological distress measured by the dass-21 (scores ≥ 5 on depression subscale of dass-21, scores ≥ 4 on anxiety subscale, or scores ≥ 8 on stress subscale) 5. having a computer/smartphone with internet access capable of doing web browsing and video-conferencing 6. being able to provide informed consent by understanding the nature of study participation. exclusion criteria: 1. having cognitive, physical, or sensory deficits, or language barriers (non-english communicator) that impede study participation 2. receiving a psychological therapy currently 3. having psychiatric hospitalizations or diagnoses of mental illness in the previous 2 years 4. taking antipsychotic or anticonvulsant medication at the time of recruitment 5. considering or planning to place family members of dementia in a nursing home within 6 months 6. having the possibility of study dropouts due to other medical conditions of family members with dementia (e.g., conditions that may impede study participation due to frequent hospitalization or death).

Keywords: caregivers dementia alzheimer's disease burden quality of life acceptance and commitment therapy mindfulness psychological health
chitosan chewing gum study in dialysis patients

Conditions: End Stage Renal Disease

Summary: the purpose of the pilot study is to determine the impact of short-term administration of chitosan-containing chewing gum on phosphate levels in patients with elevated serum phosphate levels.

the impact of using salivary phosphate binders in esrd patients is not fully known. the purpose of the pilot study is to determine the impact of short-term administration of chitosan-containing chewing gum on phosphate levels in patients with elevated serum phosphate levels.

Eligibility criteria:
inclusion criteria: * age 18-64 years old * esrd receiving hemodialysis * serum phosphate \> 6.0 mg/dl exclusion criteria: * unable to sign consent

Keywords: serum phosphate chitosan kidney disease salivary phosphate
a pivotal study to assess the safety and efficacy of the prepex system, a male circumcision device and methodology for rapid scale up of painless and bloodless national circumcision programs, in urban and remote rural settings

Conditions: Male Circumcision; HIV Prevention; HIV Infections

Summary: the protocol, approved by the rwanda national ethical committee, was issued to assess the safety and efficacy of the circumcision device for applying it to the national scale up of adult male circumcision in rwanda

multiple randomized and controlled studies (who, usaid, unaids) have proven that circumcised men in high risk areas reduce their risk of hiv infection by 60%. the government of rwanda has ranked hiv prevention as a top priority item, and wishes to decrease the hiv incidence in the country by 50%. as part of a holistic hiv prevention approach, we decided to embark upon a process of national scale up of adult male circumcision. the national hiv prevention plan calls for voluntary mc of 2 million adults by the end of 2012. the prepex system was designed to enable safe, effective, painless and bloodless male circumcision programs, to support global public health efforts to stop the spread of hiv. the prepex system includes a simple, disposable device that is easy to use and can be deployed by minimally trained healthcare professionals, in urban or rural settings, without the need for sterile, hospital settings. as such, the prepex system places minimal burden on the existing health care infrastructure to accomplish national circumcision programs. the protocol, approved by the rwanda national ethical committee, was issued to assess the safety and efficacy of the circumcision device for applying it to the national scale up of adult male circumcision in rwanda.

Eligibility criteria:
inclusion criteria: * male of ages 18 - 54 years * subject wants to be circumcised * uncircumcised * hiv sero-negative agrees to undergo measurements of width of the penis at different areas in flaccid status * able to understand the study procedures and requirements * agrees to abstain sexual intercourse and to keep caution not directly rub the cut area if masturbating, until the end of the follow-up that may take up to 6 weeks * subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study exclusion criteria: * active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision * hiv sero-positive * subject with the following diseases: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias * diabetes mellitus * subject who have an abnormal penile anatomy or any penile diseases * subject that to the opinion of the investigator is not a good candidate

Keywords: male circumcision hiv rwanda hiv seronegativity
evaluation of drug-drug interaction between lcz696 and sildenafil in subjects with mild to moderate hypertension

Conditions: Mild to Moderate Hypertension

Summary: this study was conducted to investigate the potential for a pharmacokinetic drug-drug interaction in support of the co-administration of lcz696 and sildenafil.

this study was conducted to investigate the potential for a pharmacokinetic drug-drug interaction in patients with mild-to-moderate hypertension in support of the co-administration of lcz696 and sildenafil.

Eligibility criteria:
inclusion criteria: * male subjects with mild to moderate hypertension, either treated or not currently on treatment, between age 18 and 65 years of age, and otherwise in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. * at screening: systolic blood pressure 120-140 mmhg on therapy, or 140-160 mmhg if untreated * at screening: diastolic blood pressure, 70-95 mmhg on therapy, or 90-100 mmhg if untreated * baseline: bp ≥140/90; exclusion criteria: * use of non-antihypertensive prescription drugs, herbal supplements, and/or over-the-counter (otc) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing other protocol-defined inclusion/exclusion criteria may apply.

Keywords: lcz696, sildenafil, pharmacokinetics, mild to moderate hypertension
proseal laryngeal mask airway or endotracheal tube for emergence from neuroanesthesia

Conditions: Hypertension on Emergence

Summary: extubation and emergence from anesthesia lead to systemic and cerebral hemodynamic changes that can cause cerebral edema and hemorrhage. the hemodynamic profile on emergence is more favorable if a laryngeal mask airway (lma) is inserted before neurosurgical patients emerge from anesthesia. we aimed to compare the impact of awakening neurosurgery patients after insertion of a proseal lma to replace the endotracheal tube (ett).

at the end of surgery, the anesthesiologist opened a sealed envelope labeled with software-generated randomized numbers to learn the patient's assignment to one of two groups to emerge from anesthesia with the ett still in place or after it had been replaced by an lma. hemodynamic variables were recorded at 8 moments: baseline, in the operating room one minute before anesthetic induction; 5 minutes after the end of surgery before awakening (ett group) or before tube replacement (lma group); and 1, 5, 10, 15, 30 and 60 min after extubation or lma removal (according to group assignment).

Eligibility criteria:
inclusion criteria: * elective craniotomy exclusion criteria: * difficult airway * uncontrolled hypertension before surgery * gastroesophageal reflux

Keywords: systolic blood pressure heart rate laryngeal mask endotracheal tube craniotomy
tuberoplasty versus balloon spacer

Conditions: Rotator Cuff Tears

Summary: the purpose of this study is to examine bone-to-bone contact between the tuberosity as compared to a subacromial balloon spacer procedure. using biplanar fluoroscopy to determine the three-dimensional (3d) motion of the shoulder compared pre-procedure to post-procedure, the investigators will be able to assess 1) the bone-to-bone contact of the tuberosity and acromion in the setting of a massive posterior superior rotator cuff tear 2) if the placement of a dermal allograft over the tuberosity does indeed decrease bone contact and 3) if the placement of a subacromial balloon spacer decreases bone-to-bone contact. doing so will allow assessment of the relative contribution of the implant for arm elevation versus potential compensatory motion of increased scapulothoracic motion. the investigators will also be able to correlate this to patient-reported outcomes of pain and shoulder function.


Eligibility criteria:
inclusion criteria: * massive irreparable rotator cuff tear involving the supraspinatus and infraspinatus. * no involvement of the subscapularis. * centered humeral head on x-ray examination. * primary complaint of pain. * history of prior surgery, including failed rotator cuff repair. exclusion criteria: * involvement of the subscapularis. * acromiohumeral distance less than 7 mm on upright anterior-posterior (ap) radiograph. * rotator cuff deemed repairable at the time of surgery. * patients younger than 65 years due to fda clearance of the subacromial balloon spacer only for patients over 65

Keywords: rotator cuff tear shoulder surgery tuberoplasty subacromial balloon spacer
prospective natural history study of patients with myotubular myopathy and other centronuclear myopathies

Conditions: Centronuclear Myopathy

Summary: this is the 2 years extension of the prospective and longitudinal study of the natural history and functional status of patients with myotubular myopathy and other centronuclear (cnm) sponsored by dynacure including ten additional pediatric patients with mutation in mtm1 or dnm2 genes). the patients are planned to be enrolled in one year leading to an expected total number of 70 patients followed at least over 1 year period. data from the study will be used to characterize the disease course of cnm and determine which outcome measures will be the best to assess the efficacy of potential therapies.


Eligibility criteria:
inclusion criteria: * patients of any age (newborns included) may participate * patients over 18 years of age and parent(s)/legal guardian(s) of patients \< 18 years of age must be provide written informed consent prior to participating in the study and informed assent will be obtained from minors at least 7 years of age when required by regulation. * myotubular centronuclear myopathy (mtmcnm) resulting from a mutation in the mtm1, dnm2 or bin1 gene * male or symptomatic female. a symptomatic female will be defined by the motor function assessment by motor function measure (mfm) or north star ambulatory assessment (nsaa) below 80% of the total score. * willing and able to comply with all protocol requirements and procedures. * in france only: affiliated to or a beneficiary of a social security category exclusion criteria: * other disease which may significantly interfere with the assessment of the mtm cnm and is clearly not related to the disease * currently enrolled in a treatment study; or treatment with an experimental therapy other than pyridostigmine * for women: pregnancy or current breastfeeding

Keywords: cnm xlmtm myotubular myopathy
study of targeted therapy using transcription activator-like effector nucleases in cervical precancerous lesions

Conditions: Human Papillomavirus-Related Malignant Neoplasm

Summary: this is an single arm clinical study of the safety and efficacy of t512 to possibly treat cervical intraepithelial neoplasia(cin).

persistent infection with high-risk human papillomavirus (hpvs),especially types 16 and 18,may lead to cervical intraepithelial neoplasia(cin).hpvs expresses the oncoproteins e6 and e7, both of which play key roles in maintaining viral infection and promoting carcinogenesis. previous studies showed that using designated talens (t27 and t512) targeted hpv16 e6 and e7 produced disruption of hpv16 e6 and e7 dna, decreased the expression of e6 and e7 proteins, and induced cell apoptosis. this study will evaluate the safety and efficacy of and t512 in treating hpv persistency and hpv16-positive cin.

Eligibility criteria:
inclusion criteria: * documented hpv16 infection and integration. * married and fertile, no fertility requirements. * the cervical transformation zone was type i or ii, and the biopsy results under colposcopy suggested sil. * without administration of hormone in the last six months * subjects must be meet the ethical requirements and have signed informed consent exclusion criteria: * pregnancy and breast feeding * any bacterial vaginitis * any fungal vaginitis * any sexually transmitted diseases * active drug or alcohol abuse * any hpv medications within the past 12 weeks * allergy to active or non active ingredients in the study of drugs * cardiac insufficiency * liver and renal insufficiency * hypertension and severe complications * serious illness in past 30 days * currently participating in another clinical trial or any prior gene therapy

Keywords: transcription activator-like effector nucleases human papillomavirus cervical intraepithelial neoplasia
long term follow up of patients under 5 years of age with high grade glioma diagnosed in france between 1990 and 2015

Conditions: Glioma

Summary: high grade glioma is a rare disorder affecting children at all ages with a high mortality rate. overall survival is estimated at 40%, depending on the type of treatment administered. major late sequelaes are experienced with the irradiation in this population under 5 years. therefore, the current recommendations by the french society for childhood cancers are based on a treatment including surgery followed by chemotherapy and avoiding radiotherapy as long as patients present no sign of treatment failure. the results published in 2006, underlying the fact that some patients treated exclusively with surgical resection and chemotherapy can achieve long term survival, are showing evidence of an acceptable long-term strategy. few studies concerning evaluation of treatment toxicity and long term outcomes are available. therefore, it is important to collect retrospective data concerning those small patients with high grade glioma in order to understand the reasons of treatment success or failure and treatment toxicities. this retrospective study will evaluate long term survivals comparatively to clinical, radiological and histological features at diagnosis and the treatment toxicities including neurological, endocrine and hearing impairment to go further and propose new potential guidelines and chemotherapy schedules


Eligibility criteria:
inclusion criteria: * children under 5 years old * high grade glioma (who status iii or iv) * no previous treatment with chemotherapy or radiotherapy * no contraindication to chemotherapy * consent of legal representative for participation in the study exclusion criteria: * low grade glioma * any other histological pattern * parent's denial to access data concerning their child in the frame of medical research

Keywords: glioma children chemotherapy treatment toxicitt survival
evaluation of the peripheral nerve ultrasound as a diagnostic tool in canvas neuropathies

Conditions: Neuropathy; Cerebellar Ataxia; Neurodegenerative Diseases

Summary: cerebellar ataxia with neuropathy and bilateral areflexia syndrome (canvas) is a late onset neurodegenerative disorder with a slowly progressive ataxia. it's genetic causative etiology with an autosomal recessive inheritance has a recent discovery. it is clinically characterized by impaired visually enhanced vestibulo-ocular reflex, although patients commonly present with imbalance as a main concern, associated with sensory complaints. it has been demonstrated that sensory impairment in canvas patients is due to degeneration of dorsal root with abnormal sensory nerve conduction. previously defined diagnostic criteria included cerebellar atrophy on brain mri, neuronopathy on electrophysiological studies and negative genetic testing for other inherited ataxia syndromes like friedriech ataxia and spinal cerebellar ataxia (sca). peripheral nerve ultrasound is a noninvasive technique, able to identify abnormal peripheral nerves with underlying injuries and specific sonographic characteristics. pelosi et al established that patients with canvas have a smaller nerve cross sectional area (csa) compared to healthy individuals and/ or axonal neuropathies. the main objective of this study was to obtaine a detailed description of peripheral nerves in consecutive patients with canvas syndrome followed in theneurology department of the universitary hospital of nimes (france), using conventional electrophysiology and peripheral nerve ultrasound.


Eligibility criteria:
canvas patients : inclusion criteria: * patients followed at the university hospital of nîmes between 2018-2021 * age \> 18 years * diagnosis of canvas with genetic evidence (rfc1+) * diagnosis of neuronopathy exclusion criteria: * age \<18 years * chronic polyradiculoneuritis or other demyelinating neuropathy control group, inclusion criteria : patient with axonal sensory-motor or pure sensory neuropathy confirmed by electro neuromyography, and concordant with the clinic.
evaluation of effect of combination with telmisartan and hydrochlorothiazide in hypertensives uncontrolled on amlodipine

Conditions: Essential Hypertension

Summary: the purpose of this study is to compare depressor effect and safety between combination therapy with telmisartan plus low-dose hydrochlorothiazide and amlodipine in hypertensive patients.

in hypertensive patients whose blood pressure (bp) does not reach less than 140/90 mmhg with 5mg/day of amlodipine are divided the following two groups and bp response, laboratory data, and adverse effects are compared. group 1: 12 week combination therapy with telmisartan plus low-dose hydrochlorothiazide. group 2: amlodipine is continuously administered.

Eligibility criteria:
inclusion criteria: * 5 mg/day of amlodipine is administered for more than 3 months * systolic or diastolic blood pressure \>= 140/90 mmhg (more than 2 times measurements at outpatient clinic before start of the study) * outpatients exclusion criteria: * secondary hypertension including renovascular hypertension with single kidney or bilateral stenosis * administration of antihypertensives other than amlodipine * cardiovascular disease (cerebral hemorrhage, cerebral infarction, tia, angina, myocardial infarction, acute renal failure) occurs less than 6 months before start of the study * serum creatinine \>= 2.0 mg/dl * severe hypertension (systolic or diastolic blood pressure \>= 180/110 mmhg) or malignant hypertension (hypertensive organ damage is rapidly developing) * chronic heart failure (nyha class\>=iii to vi) * contraindication of telmisartan or hydrochlorothiazide * hyper- (\>= 5.5 meq/l) or hypo- (\<=3.5 meq/l) potassemia * untreated hyperuricemia or uncontrolled hyperuricemia (serum uric acid \>= 8.0 mg/dl) * diabetic patients who require insulin therapy, uncontrolled diabetic patients (hemoglobin a1c \>=9.0%), or patients who possess the risk of hypoglycemic attack * patients inadequate for the study
characteristics and health related quality of life in idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: idiopathic pulmonary fibrosis is defined as a specific form of chronic, progressive fibrosing interstitial pneumonia of unknown cause, occurring primarily in older adults, limited to the lungs, and associated with the histopathologic and/or radiologic pattern of usual interstitial pneumonia. the definition of idiopathic pulmonary fibrosis requires the exclusion of other forms of interstitial pneumonia including other idiopathic interstitial pneumonias and interstitial lung disease associated with environmental exposure, medication, or systemic disease. prevalence estimates for idiopathic pulmonary fibrosis have varied from 2 to 29 cases per 100,000 in the general population ipf should be considered in all adult patients with unexplained chronic exertional dyspnea, and commonly presents with cough, bibasilar inspiratory crackles, and finger clubbing.

idiopathic pulmonary fibrosis should be considered in all adult patients with unexplained chronic exertional dyspnea, and commonly presents with cough, bibasilar inspiratory crackles, and finger clubbing. high resolution chest computed tomography is an essential component of the diagnostic pathway in idiopathic pulmonary fibrosis. usual interstitial pneumonia is characterized on high resolution chest computed tomography by the presence of reticular opacities, often associated with traction bronchiectasis. patients with interstitial lung disease have poor health-related quality of life. however, whether health-related quality of life differs among different subtypes of interstitial lung disease is unclear. there is limited research on the health-related quality of life of idiopathic pulmonary fibrosis patients. health-related quality of life deficits should be monitored in clinical practice with idiopathic pulmonary fibrosis patients and considered when investigating new therapies

Eligibility criteria:
inclusion criteria: * idiopathic pulmonary fibrosis will be diagnosed by presence of uip pattern. other forms of ild will be diagnosed using hrct by presence of reticular abnormality honeycombing with or without traction extensive ground glass abnormality. * profuse micronodules. exclusion criteria: * patients who refused to participate in the study.